MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD ADULT BREATHING CIRCUIT; BTT

Model Number RT202

Device Problems Moisture Damage (1405); No Apparent Adverse Event (3189)

Patient Problem Aspiration/Inhalation (1725)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Fisher & paykel healthcare is currently in the process of retrieving further information regarding the event.We will provide a follow up report upon the completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported that the rt202 adult breathing circuit was found to have had excessive condensation in the tubing.It was reported that patient experienced aspiration.No further consequences reported.

Event Description

A healthcare facility in the uk reported that the rt202 adult breathing circuit was found to have had excessive condensation in the tubing.It was reported that patient experienced aspiration.No further consequences reported.

Manufacturer Narrative

(b)(4).Method: the complaint rt202 adult breathing circuit is not returned to f&p for evaluation.No further information was received for the the questions sent to the customer.Our investigation is thus based on the initial information provided by the customer and our knowledge of the product.Results: customer reported that the patient experienced excessive condensation in the tubing during use.Conclusion: without the complaint device, the root cause of the alleged malfunction could not be conclusively determined.Condensate in the humidification system, although not preferred, is an expected side effect of heated pass-over humidification systems in many conditions and may vary between light misting to water droplets that form on the wall of cool breathing circuit tubing.The amount of condensate in the ventilation system is influenced by multiple setup and environmental factors.Our user instructions that accompany the rt202 adult breathing circuit state the following: set appropriate ventilator alarms.When mounting a humidifier adjacent to a patient ensure that the humidifier is always positioned lower than the patient.

• Brand Name: ADULT BREATHING CIRCUIT
• Type of Device: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 9089650
• MDR Text Key: 176452384
• Report Number: 9611451-2019-00900
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K983112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RT202
• Device Catalogue Number: RT202
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention